MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGIFLEX II; DILATOR, ESOPHAGEAL

Model Number	M00554510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the esophagus during a procedure performed on (b)(6) 2023.During the procedure, the esophagus was perforated.The endoscopist believed that the perforation was caused by the rigid tip of the tube rather than by balloon inflation.This was a small and localized perforation.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf patient code e1022 is being used to capture the reportable event of perforation of the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the esophagus during a procedure performed on (b)(6) 2023.During the procedure, the esophagus was perforated.The endoscopist believed that the perforation was caused by the rigid tip of the tube rather than by balloon inflation.This was a small and localized perforation.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.The patient was 72 years old male.The perforation was then treated using few endo clips.The patient undergoes nothing by mouth (nbm) and on total parenteral nutrition (tpn) due to this event.The patient had an uneventful recovery and was discharged home after a week once the barium did not demonstrate any leak.
Additional Manufacturer Narrative
Block h6: imdrf patient code e1022 is being used to capture the reportable event of perforation of the esophagus.Imdrf impact code f08 is being used to capture the reportable event of prolonged hospitalization.Imdrf impact code f2303 is being used to capture the reportable event of medication required.Block h11: additional information: block a2 (age at time of event), block b5 (describe event or problem), block h6 (impact codes) have been updated.

• Brand Name: RIGIFLEX II
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CREGANNA MEDICAL S R L; metro free trade zone; building 3 c; heredia ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18499052
• Report Number: 3005099803-2023-07133
• Device Sequence Number: 20864382
• Product Code: PID
• UDI-Device Identifier: 08714729719113
• UDI-Public: 08714729719113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K050232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: M00554510
• Device Catalogue Number: 5451
• Device Lot Number: C316128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male